There is a need in healthcare settings for efficacious broad-spectrum antimicrobial skin disinfection and hand wash products. Hand washing frequently is called the single most important measure to reduce the risks of transmitting micro organisms from one person to another or from one site to another on the same patient.
The United States Food and Drug Administration (FDA) developed performance standards for new and novel antiseptic compositions. These performance standards require a healthcare personnel hand wash to be broad spectrum and fast acting. The term broad spectrum is defined in this instance as having antimicrobial activity against a variety of gram positive and gram negative bacteria, and yeasts. The FDA set forth testing procedures by which new antiseptics are tested alongside previously approved products. Requirements for healthcare personnel hand wash are outlined in the FDA Tentative Final Monograph for Healthcare Antiseptic Drug Products (TFM) (Federal Register 59 [116], Jun. 17, 1994: pp. 31402-31452). The in vivo test procedure described beginning therein will hereinafter be referred to as the FDA TFM healthcare personnel hand wash test. Testing procedures have also been set forth in the TFM for surgical scrubs and pre-operative skin disinfecting products. A need continues to exist for healthcare personnel hand wash products with efficacy that meets the Monograph requirements, as well as other standards such as European norms.
Certain diols such as 1,2-alkane diols have been used in cosmetic products as humectants or moisturizers, and have even been shown to exhibit preservative ability when present in certain cosmetic formulations.
However, preservatives are not expected to show rapid efficacy such as that required for topical sanitizers and skin disinfecting compositions. Rather, preservatives exhibit their effects in 1 to 3 days or longer. That is, preservatives may be expected to inhibit microbial growth, but may not be sufficiently lethal to produce significant log kill of existing microbes. Additionally, many preservatives show poor activity against fungi. A need continues to exist for broad-spectrum antimicrobial products with rapid efficacy.
Others who have employed alkane diols as a preservative include U.S. Published Patent Application No. 2007/0059331, which teaches antimicrobial mixtures comprising one or more branched or unbranched alkane diols having 6-12 carbon atoms, and a tropolone. The mixtures are claimed to have a synergistic antimicrobial activity, and may be used as a preservative or antimicrobial active compound in a foodstuff or a cosmetic or a pharmaceutical formulation. Examples of formulations include sunscreen lotions and silicone emulsions.
U.S. Published Patent Application No. 2005/0222276 teaches synergistic mixtures of 1,2-alkane diols for the preservation of perishable products. They can also be used for the cosmetic treatment of microorganisms causing body odor, acne, mycoses, and for the treatment of microorganism on or in inanimate material.
U.S. Published Patent Application No. 2005/0228032 teaches a blend of 1,2-diol and phenoxyethanol and a co-biocide. The blend is suggested to control microbiological growth in personal care products.
However, a need remains for compositions having rapid, broad spectrum efficiency such as required for health care personal handwash.